MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-12-26 for MENICON Z RIGID GAS PERMEABLE LENS manufactured by Menicon Co. Ltd..
[3107276]
The info was received from safety administration section of menicon in (b)(4). A patient had pain in right eye. She was seen by her ophthalmologist and diagnosed as corneal ulcer. Then, she was referred to a hospital for admission. She was treated with erythromycin, hyaluronic acid, flavin adenine dinucleotide (fad) and tarivid (ofloxacin) ointment and intravenous drip transfusion. The total treatment time was for 15 days and the patient was discharged on (b)(6). She has returned to normal condition and her visual acuity has recovered to 0. 9 at the time of discharge. No add? L info available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614761-2012-00002 |
| MDR Report Key | 2890996 |
| Report Source | 01,07 |
| Date Received | 2012-12-26 |
| Date of Report | 2012-12-21 |
| Date of Event | 2012-11-28 |
| Date Mfgr Received | 2012-12-06 |
| Date Added to Maude | 2013-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1840 GATEWAY DRIVE 2ND FLOOR |
| Manufacturer City | SAN MATEO CA 944404 |
| Manufacturer Country | US |
| Manufacturer Postal | 944404 |
| Manufacturer G1 | MENICON CO. LTD. |
| Manufacturer Street | 21-19 AOI, 3-CHOME, NAKA-KU |
| Manufacturer City | NAGOYA, AICHI |
| Manufacturer Country | JA |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENICON Z RIGID GAS PERMEABLE LENS |
| Generic Name | RGP CONTACT LENS |
| Product Code | MWL |
| Date Received | 2012-12-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENICON CO. LTD. |
| Manufacturer Address | 21-19 AOI, 3-CHOME, NAKA-KU NAGOYA, AICHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-26 |